Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Absolute neutrophil count (ANC) >= 1.5 X 10^9/L without (w/o) myeloid growth factor support for 7 days preceding lab assessment, obtained within 14 days prior to PET scan.
- - Hemoglobin (Hgb) >= 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if Hgb is corrected to >= 9 g/dL (90 g/L) as by growth factor or transfusion prior to PET scan, obtained within 14 days prior to PET scan.
- - Platelet count >= 100 X 10^9/L w/o blood transfusions for 7 days preceding lab assessment, obtained within 14 days prior to PET scan.
- - Bilirubin = < 1.5 X upper limit of normal (ULN) except for patients (pts) with (w/) documented history of Gilbert?s disease, obtained within 14 days prior to PET scan.
- - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 X ULN, obtained within 14 days prior to PET scan.
- - Alkaline phosphatase (AP) =< 3 X ULN, obtained within 14 days prior to PET scan.
- - Women of childbearing potential (WCBP): negative serum pregnancy test, obtained within 14 days prior to PET scan.
- - Karnofsky performance status (KPS) >= 60 (Parts 2 [intracranial tumor patients] and 3 [recurrent glioblastoma (GBM) patients] ONLY) - Ability to understand and the willingness to sign a written informed consent document.
- - (Part 2, intracranial tumor patients ONLY): Radiographical or pathological evidence of an intracranial tumor.
- - (Part 3, suspected GBM patients ONLY): Any patient with histopathologically proven GBM who, on a standard of care surveillance brain magnetic resonance imaging (MRI), has an imaging change suspicious for GBM recurrence, and whose treatment plan for the recurrence does not include surgery.
- - (Part 3, suspected GBM patients ONLY): Life expectancy of >= 6 months.
- - Known allergy to adhesive tapes or other skin adhesives used in medical care.
- - Known cirrhosis diagnosed with Child Pugh class A or higher liver disease.
- - Severe/uncontrolled inter current illness within the previous 28 days prior to PET scan.
- - Patients who have implantable devices that are contraindicated for MRI.
- - Bleeding disorder.
- - Any other significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
- - Additional exclusion criterion for healthy volunteers (Part 1 and Part 4 ONLY) - Prior or current malignancy.
- - Known kidney disease.
- - Pregnant or nursing participants.
- - History of allergic reactions to gadolinium-based MRI contrast agent.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Guido A. Davidzon, MD, MS|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Guido A Davidzon, MD|
|Principal Investigator Affiliation||Stanford Cancer Institute Palo Alto|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Healthy Subject, Intracranial Neoplasm, Glioblastoma|
- I. Determine whether the fluorine F 18 DASA-23 ([18F]DASA 23) PET scan signal change from pre-therapy to one week after initiation of therapy can predict the tumor's responsiveness to therapy and 6 month progression free survival (PFS6), in suspected recurrent glioblastoma.
- I. Determine the sensitivity, specificity, and accuracy of [18F]DASA-23 PET imaging in identifying intracranial tumors in patients with intracranial tumors.
- II. Determine whether the [18F]DASA-23 PET scan signal change from pre therapy to one week after initiation of therapy can predict progression free survival (PFS) and overall survival (OS), in suspected recurrent glioblastoma.
Active Comparator: Group I ([18F]DASA-23, PET)
Healthy volunteers receive [18F]DASA-23 IV and undergo brain PET scan over 15 minutes and 4 vertex-to-toe PET scans over 30 minutes each.
Experimental: Group II ([18F]DASA-23, PET)
Intracranial tumor participants receive [18F]DASA-23 IV and undergo brain PET scan over 60 minutes and 1 vertex-to-toe PET scan over 30 minutes.
Experimental: Group III ([18F]DASA-23, PET)
Patients with at least a 1cm3 contrast-enhancing lesion suspicious for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM) on a standard-of-care (SOC) brain MRI scan. If the patient undergoes a biopsy or resection for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM) then the remaining contrast-enhancing lesion is at least 1cm3 in size on the post-operative scan. These patients will undergo one [18F]DASA 23 PET/MRI scan before the initiation of therapy, and a second/final [18F]DASA 23 PET/MRI scan within 2-6 weeks after initiation of therapy for their GBM.
Active Comparator: Group IV ([18F]DASA-23, PET)
Healthy volunteers receive [18F]DASA-23 IV and undergo brain PET/MRI brain scan for 60 mins
Drug: - Fluorine F 18 DASA-23
Procedure: - Positron Emission Tomography
Undergo PET scan
Contact a Trial Team
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